UniCel Dxl 600 Access Immunoassay System, Part Numbers: A30260, A71460, and A71461.
The UniCel DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids. The UniCel DxC series of instruments is a DxI Immunoassay System integrated with a chemistry analyzer.

Code Information

Serial Numbers: 900000 through 900491.

Recalling Firm/Manufacturer

Beckman Coulter Inc.250 S Kraemer BlvdBrea, California 92821-6232

For Additional Information Contact

Clair K. O'Donovan, Ph.D.714-961-4483

Manufacturer Reasonfor Recall

The recall was initiated because Beckman Coulter has confirmed that the UniCel Dxl and DxC Access Immunoassay Systems had field modifications to the aspirate and dispense probe assemblies.

FDA DeterminedCause 2

DESIGN: Process Design

Action

Beckman Coulter sent a field modification was released in August 2011 which included:
- Installing a new aspirate and dispense tubing routing bracket.
- Replacing existing aspirate and dispense probe tubing with modified tubing to help eliminatemisrouting of aspirate and dispense probe tubing.
During installation the FSE informed the customer:
-That aspirate and dispense tubing are different lengths.
- That probes are not interchangeable with other instruments once tubing has been modified.
- To route probe tubing by referring to the labels on the tubing.
An updated service document, Routine Maintenance Changes, A82294B was provided to every customer.
For questions regarding this recall call 714-961-4483.